Chiasma Reports Second Quarter 2020 Results and Significant Progress on Launch Preparedness
On track to announce MPOWERED Phase 3 trial topline data in the fourth quarter
Company to host conference call today,
Recent Business Highlights
- Achieved FDA approval of MYCAPSSA®, the first and only oral somatostatin analog with the potential to become the new standard of pharmacological care in the long-term maintenance treatment of patients with acromegaly.
- Demonstrated longer-term durability of efficacy and safety of MYCAPSSA in the 48-week open-label extension (OLE) of the Phase 3 CHIASMA OPTIMAL study.
- Bolstered a top-tier launch team including the appointment of biopharmaceutical commercial veteran
Anand Varadanas EVP, Chief Commercial Officer.
- Secured up to
$75 millionto support the planned commercial launch of MYCAPSSA through a revenue interest financing agreement with HealthCare Royalty Partners(HCR).
- Raised approximately
$75 millionof net proceeds through an over-subscribed equity financing.
Anticipated Upcoming 2020 Milestones
U.S.commercial launch of MYCAPSSA planned to commence in the fourth quarter.
- FDA acceptance and approval of manufacturing supplement to approved MYCAPSSA new drug application (NDA) to include the primary commercial active pharmaceutical ingredient supplier.
- Top-line MPOWERED™ Phase 3 clinical trial results expected to be announced in the fourth quarter.
“We made significant progress since our last quarterly update, most notably our transition to a commercial stage company following the FDA’s approval in June of MYCAPSSA as a novel treatment for acromegaly,” stated
“In parallel, we continue to add to the robust dataset for MYCAPSSA. Notably, the data from the 48-week open-label extension of the CHIASMA OPTIMAL trial demonstrated longer-term durability of safety and efficacy of MYCAPSSA and highlights the strong preference of these acromegaly patients for an oral treatment alternative. We look forward to advancing MYCAPSSA as a preferred treatment option for patients with acromegaly treated with octreotide and lanreotide injectables,”
Second Quarter 2020 Financial Results
- G&A Expenses: General and administrative expenses were
$10.7 millionfor the second quarter ended June 30, 2020, compared with $2.6 millionfor the same period of 2019. The current year results include $5.6 millionof ongoing pre-commercial activities, an increase in compensation-related expenses, and increased other administrative costs as we prepared for the planned commercialization of octreotide capsules in the U.S.in the fourth quarter of this year.
- R&D Expenses: Research and development expenses were
$9.7 millionfor the second quarter ended June 30, 2020, compared with $5.5 millionfor the same period of 2019. The increase in current period results was primarily driven by the manufacturing of octreotide capsules to support our commercial launch, costs associated with our disease state registry, scientific literature publications and increased regulatory costs which were offset by a decrease in clinical trial costs.
- Net Loss: For the quarter ended
June 30, 2020, net loss was ($21.1) million, or ( $0.50) per basic share, compared with ($7.8) million, or ( $0.25) per basic share, in the same period of 2019.
- Cash Position: Chiasma ended the second quarter with cash, cash equivalents, marketable securities and restricted cash of
$87.1 million, compared with $92.4 millionas of December 31, 2019. In April 2020, the company received a $25 millionpayment, less certain transaction expenses, from Healthcare Royalty Partnersunder the previously announced revenue interest financing agreement. In July, the company received an additional $25 millionfrom HCR, triggered by FDA approval of MYCAPSSA. Additionally, also in July, Chiasma raised approximately $75 millionof net proceeds from an over-subscribed underwritten public offering of common stock and pre-funded warrants.
Conference Call and Webcast Information
Chiasma management will host a conference call and webcast to discuss the second quarter results in more detail today,
A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company’s website approximately two hours after the event. The archived webcast will be available for one year.
MPOWERED™ Phase 3 Trial
Chiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the Company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED, is a global, randomized, open-label and active-controlled, 15-month trial intended to support approval in the
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Hypersensitivity to octreotide or any of the components of MYCAPSSA. MYCAPSSA can cause a serious allergic reaction including anaphylactic shock.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Gallbladder abnormalities may occur. Monitor periodically. Discontinue if complications of cholelithiasis are suspected.
- Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and antidiabetic treatment may need adjustment.
- Hypothyroidism may occur. Monitor thyroid levels periodically.
- Bradycardia, arrhythmia or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need adjustment.
- Decreased vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment.
The most common adverse reactions (incidence >10 %) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, oral hypoglycemic agents, beta‑blockers, bromocriptine. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.
Advise premenopausal females of the potential for an unintended pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The full Prescribing Information for MYCAPSSA will be made available at www.MYCAPSSA.com.
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. The company estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in
Chiasma is commercial-stage company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding plans for and the commercialization of MYCAPSSA, statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care, and the anticipated market acceptance of MYCAPSSA, statements regarding the data from the open label extension of the CHIASMA OPTIMAL trial, statements regarding the company’s expectations relating to the manufacturing supplement it submitted to the FDA and the company’s expectations regarding the availability of product supply, statements concerning the timing and success of a potential commercial launch of MYCAPSSA in
|Condensed Consolidated Statements of Operations|
|(amounts in thousands except share and per share data)|
|For the three months ended||For the six months ended|
|General and administrative||$||10,665||$||2,644||$||18,247||$||5,094|
|Research and development||9,672||5,522||17,797||11,993|
|Total operating expenses||20,337||8,166||36,044||17,087|
|Loss from operations||(20,337||)||(8,166||)||(36,044||)||(17,087||)|
|Interest and other income, net||128||341||526||525|
|Loss before income taxes||(21,116||)||(7,825||)||(36,425||)||(16,562||)|
|Provision for income taxes||12||15||89||28|
|Earnings per share of common stock:|
|Weighted-average shares outstanding:|
|Condensed Consolidated Balance Sheets Information|
|(amounts in thousands)|
|Cash and cash equivalents||$||52,194||$||27,855|
|Prepaid expenses and other current assets||3,741||3,881|
|Property and equipment, net||617||334|
|Other current liabilities||716||546|
|Deferred royalty obligation||24,601||-|
|Total stockholders' equity||51,978||85,769|
|Total liabilities and stockholders' equity||$||93,966||$||98,826|